System for remote site production of Sterile Water for Injection (SWFI) and Saline

The applicant developed the modular Sterile Saline Solution System (S4), for remote site production of Sterile Physiologic Saline. It used Available Surface Water of poorer quality for particulates, chemical contaminants, microbes and biologicals than the EPA Grade Drinking Water Standards (EGDWS) specifies and dry reagent formulation. This system is the subject of an FDA assigned Investigational New Drug Application (IND 66,005) for this S4.A revised version of the S4, the RS4, met this topics Phase II specifications objectives for weight (0.7 pounds), cube (0.04 ft3), flow rate (1,000 mL/min) and operated without power. RS4 was developed within Office of Naval Research contracts. It produced Sterile Physiologic Saline that met the quality attributes set by the U.S. Pharmacopeia for this solution with the exception of not starting with EGDWS water. It is anticipated that a similar system using EGDWS plus in theater drinking water contaminants; could produce the specified volume objectives at the objective flow rate within the weight and cube objectives without power. Recent materials advances, improved purification mechanisms and availability of therapeutic agents will be reviewed to determine if the revised design could enable improved flow rates, purification, production volumes, cycle objectives and product solution diversity.